Patient participation in cancer clinical trials: A pilot test of lay navigation.

BACKGROUND: Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. METHODS: A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-minute CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. RESULTS: During this 12-month pilot project, 85% (95% CI: 72%-93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%-98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation. CONCLUSIONS: In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Racial and Ethnic Group Knowledge, Perceptions and Behaviors about Human Papillomavirus, Human Papillomavirus Vaccination, and Cervical Cancer among Adolescent Females.

STUDY OBJECTIVE: Human papillomavirus (HPV) vaccines provide an opportunity to greatly reduce the burden of cervical cancer. Although there has been improvement in uptake, there are notable ethnic/racial disparities. This qualitative study was conducted to better understand factors related to vaccine uptake among female adolescents from 3 racial/ethnic groups: African American (AA), Hispanic, and Caucasian. Findings can inform the development of optimal messages and strategies for clinical and population-based interventions. DESIGN AND SETTING: This mixed-methods descriptive study included completion of a brief structured survey and focus group discussion. Six focus groups were conducted with female adolescents, 2 each in the AA, Hispanic, and Caucasian groups. Brief structured survey questions and the focus group protocol addressed knowledge, perceptions, and behaviors related to HPV, HPV vaccination, and cervical cancer. PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: Participants were 60 female adolescents (ages 13-19, mean age = 16.6 years) recruited from high schools, public health clinics, and churches. RESULTS: Themes across questions were remarkably similar among AA, Hispanic, and Caucasian participants. Each group had high awareness of the terms HPV, HPV vaccination, and cervical cancer, but with little in-depth knowledge about these topics. There was a high acceptance of HPV vaccination. Misperceptions about optimal cervical cancer prevention strategies such as simply knowing one's partner and good hygiene were most common among Hispanic adolescents. Awareness about Pap testing was most common among Caucasian adolescents. CONCLUSION: Predominantly uniform perceptions of HPV vaccines across racial/ethnic groups suggest a "one size fits all" approach will likely have greater reach with cervical cancer prevention messaging than culturally tailored interventions.

Cryotherapy and ankle motion in chronic venous disorders.

This study compared ankle range of motion (AROM) including dorsiflexion, plantar flexion, inversion and eversion, and venous refill time (VRT) in leg skin inflamed by venous disorders, before and after a new cryotherapy ulcer prevention treatment. Fifty-seven-individuals participated in the randomized clinical trial; 28 in the experimental group and 29 received usual care only. Results revealed no statistically significant differences between the experimental and usual care groups although AROM measures in the experimental group showed a consistent, non-clinically relevant decrease compared to the usual care group except for dorsiflexion. Within treatment group comparisons of VRT results showed a statistically significant increase in both dorsiflexion and plantar flexion for patients with severe VRT in the experimental group (6.9 ± 6.8; p = 0.002 and 5.8 ± 12.6; p = 0.02, respectively). Cryotherapy did not further restrict already compromised AROM, and in some cases, there were minor improvements.

The effect of a cryotherapy gel wrap on the microcirculation of skin affected by chronic venous disorders.

AIM: The aim of this randomized clinical trial was to investigate a cryotherapy (cooling) gel wrap applied to lower leg skin affected by chronic venous disorders to determine whether therapeutic cooling improves skin microcirculation. BACKGROUND: Chronic venous disorders are under-recognized vascular health problems that result in severe skin damage and ulcerations of the lower legs. Impaired skin microcirculation contributes to venous leg ulcer development, thus new prevention therapies should address the microcirculation to prevent venous leg ulcers. METHODS: Sixty participants (n = 30 per group) were randomized to receive one of two daily 30-minute interventions for four weeks. The treatment group applied the cryotherapy gel wrap around the affected lower leg skin, or compression and elevated the legs on a special pillow each evening at bedtime. The standard care group wore compression and elevated the legs only. Laboratory pre- and post-measures included microcirculation measures of skin temperature with a thermistor, blood flow with a laser Doppler flowmeter, and venous refill time with a photoplethysmograph. Data were collected between 2008 2009 and analysed using descriptive statistics, paired t-tests or Wilcoxon signed ranks tests, logistic regression analyses, and mixed model analyses. RESULTS: Fifty-seven participants (treatment = 28; standard care = 29) completed the study. The mean age was 62 years, 70% female, 50% African American. In the final adjusted model, there was a statistically significant decrease in blood flow between the two groups (-6.2[-11.8; -0.6], P = 0.03). No statistically significant differences were noted in temperature or venous refill time. CONCLUSION: Study findings suggest that cryotherapy improves blood flow by slowing movement within the microcirculation and thus might potentially provide a therapeutic benefit to prevent leg ulcers.

Investigating critically ill patients' and families' perceptions of likelihood of survival.

OBJECTIVE: This study investigated the perception of chance for survival among critically ill patients and surrogates and compared those perceptions to actual survival and to clinical estimates of illness severity. Secondary aims explored whether select demographic, clinical, or personal measures were associated with different perceptions of chance for survival. DESIGN: Prospective, sequential, observational, survey-based study. Primary measures were perception of chance for survival as compared to actual survival and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores. SETTING: Tertiary care, academic medical intensive care unit (MICU). PATIENTS: Subjects were English-speaking adult MICU patients with a MICU length-of-stay greater than three days or their surrogates (n = 100). RESULTS: Respondents tended to be more optimistic regarding chance for survival than supported by actual survival (p = 0.07) or APACHE II tertile (p = 0.34). Secondary analyses found African American race, faith, or religion impacting health decision-making, and higher health status reports were associated with more optimistic perceptions of chance for survival. CONCLUSION: Patient/surrogate perceptions of chance for survival were not associated with either actual MICU survival or illness severity (APACHE II) highlighting an opportunity to better inform critically ill patients and families regarding prognosis. Clinician recognition of patients' and families' backgrounds and values might set the stage for such discussions.

Barriers to genetic testing among persons at risk for alpha-1 antitrypsin deficiency.

The alpha coded testing (ACT) study offers free and confidential testing for alpha-1 antitrypsin deficiency (AATD) and includes surveys to provide data to study the psychosocial correlates of genetic testing. The purpose of the current study is to better understand reasons why some individuals complete genetic testing while others do not. Survey measures were compared between participants who requested and returned a genetic test for AATD (n = 703), and a random sample of individuals who requested a test kit, but did not return it within 3 months of their request (n = 83). Increasing decile of age (odds ratio [OR] = 0.74 [95% confidence interval = 0.60-0.82]) and fingerstick fear (OR = 0.74 [0.60-0.93]) were associated with a decreased likelihood of returning the test, while assurance of confidentiality was associated with an increased likelihood (OR = 1.26 [1.01-1.57]) of returning the genetic test. General anxiety as measured by the Beck Anxiety Inventory, family functioning as measured by the general functioning subscale of the Family Assessment Device, and stress induced by genetic testing as measured by the Impact of Events Scale did not significantly differ between responder groups (p = not significant). Results of this study help characterize factors driving genetic testing in AATD and may offer insight into population responses with other genetic tests.

Advanced heart failure: prognosis, uncertainty, and decision making.

Heart failure is a serious clinical management challenge for both patients and primary care physicians. The authors studied the perceptions and practices of internal medicine residents and faculty at an academic medical center in the Southeast to guide design of strategies to improve heart failure care. Data were collected via a self-administered survey. Eighty-nine faculty and resident physicians in general internal medicine and geriatrics participated (74% response rate). Items measured perceived skills and barriers, adherence to guidelines, and physician understanding of patient prognosis. Case studies explored practice approaches. Clinical knowledge and related scales were generally good and comparable between physician groups. Palliative care and prognostic skills were self-rated with wide variance. Physicians rated patient noncompliance and low lifestyle change motivation as major barriers. Given the complexities of caring for elderly persons with heart failure and comorbid conditions, there are significant opportunities for improving physician skills in decision making, patient-centered counseling, and palliative care.

Improving colorectal cancer screening in primary care practice: innovative strategies and future directions.

Colorectal cancer (CRC) screening has been supported by strong research evidence and recommended in clinical practice guidelines for more than a decade. Yet screening rates in the United States remain low, especially relative to other preventable diseases such as breast and cervical cancer. To understand the reasons, the National Cancer Institute and Agency for Healthcare Research and Quality sponsored a review of CRC screening implementation in primary care and a program of research funded by these organizations. The evidence base for improving CRC screening supports the value of a New Model of Primary Care Delivery: 1. a team approach, in which responsibility for screening tasks is shared among other members of the practice, would help address physicians' lack of time for preventive care; 2. information systems can identify eligible patients and remind them when screening is due; 3. involving patients in decisions about their own care may enhance screening participation; 4. monitoring practice performance, supported by information systems, can help target patients at increased risk because of family history or social disadvantage; 5. reimbursement for services outside the traditional provider-patient encounter, such as telephone and e-mail contacts, may foster enhanced screening delivery; 6. training opportunities in communication, cultural competence, and use of information technologies would improve provider competence in core elements of screening programs. Improvement in CRC screening rates largely depends on the efforts of primary care practices to implement effective systems and procedures for screening delivery. Active engagement and support of practices are essential for the enormous potential of CRC screening to be realized.

Care at the end of life: focus on communication and race.

OBJECTIVE: To profile communication and recommendations reported by adults with terminal illness and explore differences by patient and physician characteristics. METHOD: This pilot was a cross-sectional study sample of 90 patients (39 Caucasian, 51 African American) with advanced heart failure or cancer. Participants completed an in-person, race-matched interview. RESULTS: Participation was high (94%). DISCUSSION: For example, only 30% reported discussion of advance directives, and 22% reported their physician inquired about spiritual support. Participants with cancer were significantly more likely to be receiving pain and/or symptom management at home, aware of prognosis, and participating in hospice. African American participants who were under the care of African American physicians were less likely to report pain and/or symptom management than other racial matches.Discussion: Although additional research on factors related to communication is important, initiation of patient-centered counseling by all physicians with seriously ill patients is essential.

Physician perspectives on end-of-life care: factors of race, specialty, and geography.

OBJECTIVES: To describe physicians' end-of-life practices, perceptions regarding end-of-life care and characterize differences based upon physician specialty and demographic characteristics. To illuminate physicians' perceptions about differences among their African-American and Caucasian patients' preferences for end-of-life care. DESIGN AND METHODS: Twenty-four African-American and 16 Caucasian physicians (N=40) participated in an in-person interview including 23 primary care physicians, 7 cardiologists, and 10 oncologists. Twenty-four practices were in urban areas and 16 were in rural counties. RESULTS: Physicians perceived racial differences in preferences for end-of-life care between their Caucasian and African-American patients. Whereas oncologists and primary care physicians overwhelmingly reported having working relationships with hospice, only 57% of cardiologists reported having those contacts. African-American physicians were more likely than Caucasian physicians to perceive racial differences in their patients preferences for pain medication. SIGNIFICANCE OF RESULTS: Demographic factors such as race of physician and patient may impact the provider's perspective on end-of-life care including processes of care and communication with patients.

Print information to inform decisions about mammography screening participation in 16 countries with population-based programs.

OBJECTIVE: To profile and compare the content and presentation of written communications related to informed decision-making about mammography. METHODS: Materials from 16 screening programs organized at the national or regional level were analyzed according to five major information domains suggested by the international literature. RESULTS: A majority of countries provided information on the program (interval, cost and quality). There was considerable variability in comprehensiveness of elements in the domains, e.g., test characteristics (false positive/negative) and pros and cons of screening. The majority noted the likelihood of recall for further tests, few commented on the risks of additional tests or finding unimportant tumors. The audit also found variation in presentation (words and pictures). CONCLUSIONS: Presentation of comprehensive, but balanced information on screening benefits and risks is complex and daunting. Issues such as framing effects, coupled with debate about screening efficacy are challenging to the design of effective information tools. The objective of increasing screening prevalence at the population level must be balanced with objectively presenting complete and clear information. Additional research is needed on how information (and mode of presentation) impact screening decisions. PRACTICE IMPLICATIONS: Public health officials need to articulate their objectives and review written communication according to important decision-making domains.

An interdisciplinary workshop to improve palliative care: advanced heart failure--clinical guidelines and healing words.

OBJECTIVE: Effective communication is recognized as an essential process to providing quality care, including palliative and end-of-life care. Discussion of prognosis and support needs of patients with heart failure is particularly challenging given the nature of the condition and care across several settings. The objective was to design, implement, and evaluate an interdisciplinary workshop aimed at improving attitudes and skills related to communication with patients and family, health team communication and documentation, and assessment of physical and emotional symptoms. METHODS: A pretest, delayed posttest evaluation design was used to evaluate two 4-h workshops offered to nurses, social workers, and other nonphysician clinicians. RESULTS: Although baseline reports of skills were high for the participants, significant improvement was noted for objectives emphasized in the workshop. SIGNIFICANCE OF RESULTS: This project demonstrated the feasibility of designing, marketing a brief workshop, and positively impacting communication and documentation skills.

Mammography screening after breast cancer diagnosis in a first degree female relative: age group differences (United States).

OBJECTIVES: To examine age group differences in predictors of mammography screening in women with a first-degree female relative (FDFR) with recent diagnosis of breast cancer. METHODS: A cohort study of 577 women ages 18 and over with a FDFR diagnosed with incident stage 0-III breast cancer was conducted. Telephone interviews were conducted at baseline, 6 months and 12 months. Logistic regression was used to model factors associated with mammography screening since diagnosis. RESULTS: Mammography rates were 32%, 71% and 75% for women aged 18-39, 40-49 and 50 and above, respectively. Among the youngest group, belief in cancer screening effectiveness, mammography history and MD recommendation predicted mammography. For those 40-49, excellent self-rated health, perceived similarity of personality to the patient and higher intrusive thoughts predicted mammography. Perceived similarity of health care utilization to the patient and higher risk perceptions were associated with mammography among women aged 50 and above. CONCLUSIONS: Mammography rates were high among women aged 40-49 and 50 and above, and considerable among women aged 18-30, even in view of the lack of evidence-based guidelines. Continued attention should be paid to the 25-30% of older women who do not report screening.

A path analysis of factors associated with distress among first-degree female relatives of women with breast cancer diagnosis.

Patterns and predictors of psychological distress in first-degree female relatives (N = 624) of newly diagnosed breast cancer patients were explored. First-degree female relatives who were high monitors reported greater cancer-specific and general distress than did low monitors. Greater optimism was associated with lower cancer-specific distress. Optimism's effect on general distress was moderated by women's level of monitoring. Greater optimism was associated with lower general distress for both high and low monitors, but the effect was stronger for high monitors than for low monitors. Avoidance and engaged coping were associated with higher distress. A close relationship with the cancer patient was related to higher cancer-specific distress but lower general distress. Further understanding of the process of adjustment in these women awaits longitudinal study.

End-of-life communication and hospital nurses: an educational pilot.

Heart failure is a high prevalence, high burden disease with an unpredictable trajectory. Given that approximately 50% of persons with the diagnosis die within 5 years, the implications for communication about advance planning and end of life, although simultaneously providing hope and treatment, are extremely challenging. This article reports on a feasibility trial of a modest continuing education seminar to increase awareness and communication skills of inpatient nurses. Curriculum design details, including objectives and methods, are described. Needs assessment and evaluation data are reported. At the 2-month posttest, a summary communications skill score showed significant improvement. Data also illustrated that the challenge of facing issues about dying are complicated by a work force of relatively young staff and low exposure to few actual deaths during relatively short lengths of stay.

Challenges to research in urban community health centers.

Community health centers (CHCs) are important settings for research aimed at reducing health disparities. However, CHCs pose many challenges to research at patient, provider, and system levels. We summarized lessons learned from a multimethod, formative study to develop intervention strategies for improving colorectal cancer screening in CHCs, and make recommendations for future research. The call for research in "real world" settings such as CHCs must be matched with greater understanding of the challenges, as well as the resources to meet those challenges.

Characteristics of women refusing follow-up for tests or symptoms suggestive of breast cancer.

BACKGROUND: Delay in diagnosis of breast cancer can occur at several points on the diagnostic pathway. We examined characteristics of women with breast cancer who before diagnosis actively refused recommended follow-up of tests or symptoms suggestive of breast cancer. METHODS: We identified women aged 50 years or older diagnosed with late-stage (metastatic disease or tumors > or = 3 cm at diagnosis) and a matched sample of women with early-stage (tumors < 3 cm) breast cancer from 1995 to 1999. Using medical records, we investigated clinical characteristics, use of health care, and documentation of care refusal during the 3 years before diagnosis. We used logistic regression models to compare refusers to nonrefusers. RESULTS: Of the 2694 women studied, 7.2% refused provider follow-up advice during the 3 years. These women were more likely to have late-stage breast cancer at diagnosis than were nonrefusers (odds ratio [OR] = 1.9, 95% confidence interval [CI] = 1.4 to 2.6). They were more likely to be aged 75 years or older (OR = 1.9, 95% CI = 1.4 to 2.7 compared with age 50-64) or to have six or more children (OR = 2.3, 95% CI = 1.3 to 4.2 compared to women with one to two children). Clinical factors associated with refusal included low use of mammography, high use of clinical breast exam, and missed appointments. A minority of women who refused had a reason documented in the medical record; the most frequent reasons were avoidance-denial-fatalism, fear of diagnostic tests, and fear of surgery or disfigurement. CONCLUSIONS: Our results suggest that certain demographic and clinical characteristics are associated with women's refusal of diagnostic testing for breast cancer. Further study is needed on refusers' characteristics and on how such refusals affect outcomes. Efforts aimed at identifying and counseling women with abnormal results who refuse follow-up are warranted.

Breast and cervical cancer screening: clinicians' views on health plan guidelines and implementation efforts.

BACKGROUND: Optimizing breast and cervical cancer screening rates within health plans requires clinician support for screening guidelines, an awareness of whether there are tools available and functioning to aid screening implementation, and a perception of collegial and leadership support for quality screening services. This study investigated clinicians' perceptions of guidelines, reminders for screening, and plan and practice commitment in order to assess where opportunities exist to improve the screening process. METHODS: A stratified sample of 761 primary care clinicians from three comprehensive health plans were surveyed to assess awareness of and agreement with guideline elements, perception of guidelines' usefulness, awareness of plan strategies to promote guideline adherence, perception of support for high-quality screening services, and ratings of plan efforts to maximize members' access. RESULTS: Clinician awareness of and agreement with guideline elements was high (98% breast, 94% cervical). Across guideline elements, agreement was lower for mammography than cervical screening, notably for upper age limit recommendations (58% breast, 79% cervical). Knowledge of systems that cue patients and clinicians that screening is due varied by cancer test, and clinician report and plan report data about the existence of systems were, at times, not congruent. Views about consistent operation of systems differed by test (mammograms, 74%-92%; Pap, 66%-84%). Clinicians rated local colleagues and local and plan medical leadership as very committed to high-quality screening, albeit with somewhat lower ratings for cervical testing. Although the majority rated overall plan efforts to maximize screening as very good or excellent, perceived consistency of systems to cue a woman that she is due for testing and perception of collegial support were independently and significantly related to ratings of plan efforts. CONCLUSIONS: Improvements in knowledge of systems that support guideline implementation varied, and action to ensure accurate perception of reminders, as well as consistent implementation of systems, may be important for improving screening rates and outcomes. Plan efforts and clinician efforts at the practice level are closely linked and need to be aligned to maximize screening rates. This requires plan and practice-level analyses of structures and processes that could be improved.

Relationship between tobacco control policies and the delivery of smoking cessation services in nonprofit HMOs.

BACKGROUND: This project examined tobacco policies and delivery of cessation services in nonprofit HMOs that collectively provide comprehensive medical care to more than 8 million members. METHODS: Three annual surveys with health plan managers showed that all of these health plans had written tobacco control guidelines that became more comprehensive over the span of this study. We also surveyed a random sample of 4207 current smokers who had attended a primary care visit in the past year (399-528 at each of nine health plans). RESULTS: Of these smokers, 71% reported advice to quit, 56% were asked about their willingness to quit, 49% were provided some assistance in quitting (mostly self-help material or information about classes or counseling), and 9% were offered some kind of follow-up. Smokers receiving assistance in quitting reported higher satisfaction with their care. CONCLUSIONS: In general, health plans with the most comprehensive policies also showed higher rates of implementing tobacco treatment programs in primary care. Compared with tobacco control efforts of a decade or more ago, considerable progress has been made. However, there is still room for improvement in the proportion of smokers who receive the most effective forms of assistance in quitting.